Rofecoxib and inflammatory bowel disease: clinical and pathologic observations.

OBJECTIVES

To describe clinical and pathologic findings in patients noted to develop lower gastrointestinal symptoms when exposed to rofecoxib.

METHODS

Case reports and associated biopsy findings.

RESULTS

Three patients who developed symptoms of inflammatory bowel disease (IBD) during rofecoxib exposure are described along with pathology findings. Two episodes were incident cases (no prior IBD); one episode was recurrent colitis or a nonincident case (flare of prior IBD). All symptoms resolved with drug withdrawal.

CONCLUSIONS

Symptoms and pathologic changes of colitis are associated with exposure to rofecoxib. Abnormalities resolve with drug withdrawal.